Rotatable Clip Fixing Device HX-110URRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04953170200229), received between Mar 29, 2022 and Sep 27, 2024 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE ROTATABLE CLIP FIXING DEVICE EXHIBITED OPERATING WIRE COATING OF APPLICATOR PEELED OFF AND FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20322523 ↗
• MalfunctionSep 20, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE ROTATABLE CLIP FIXING DEVICE OPERATING WIRE WAS PEELED AND DISLODGED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268296 ↗
• MalfunctionJul 12, 2024Material Fragmentation; Peeled/Delaminated; Material Fragmentation; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ROTATABLE CLIP FIXING DEVICE HAD EXHIBITED THE COATING OF THE OPERATION WIRE WAS PEELED OFF AND FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733468 ↗
• MalfunctionMay 20, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE WIRE COATING OF THE ROTATABLE CLIP FIXING DEVICE HAD PEELED AND FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355308 ↗
• MalfunctionMay 20, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE WIRE COATING OF THE ROTATABLE CLIP FIXING DEVICE HAD PEELED AND FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355297 ↗
• MalfunctionMay 20, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE WIRE COATING OF THE ROTATABLE CLIP FIXING DEVICE HAD PEELED AND FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355285 ↗
• MalfunctionMay 16, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ROTATABLE CLIP FIXING DEVICE EXHIBITED THE COATING ON THE OPERATING WIRE HAD PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19334913 ↗
• MalfunctionMay 16, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ROTATABLE CLIP FIXING DEVICE EXHIBITED THE COATING ON THE OPERATING WIRE HAD PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19334796 ↗
• MalfunctionApr 18, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE ROTATABLE CLIP FIXING DEVICE EXHIBITED WIRE COATING PEELED OFF AND FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140858 ↗
• InjuryApr 11, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, WHEN THE CLIP WAS USED IN COMBINATION WITH THE ROTATABLE CLIP FIXING DEVICE DURING A POLYPECTOMY, THE CLIP DID NOT COME OFF THE SHEATH AND WAS PULLED WHILE GRASPING THE MUCOUS MEMBRANE, RESULTING IN HEAVY BLEEDING. THE PHYSICIAN MANUALLY SUTURED THE RECTUM, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19088919 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT THERE WAS NO MALFUNCTION OF AN OLYMPUS DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18986061 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "ENDOSCOPIC FULL-THICKNESS RESECTION VERSUS ENDOSCOPIC SUBMUCOSAL DISSECTION IN THE TREATMENT OF COLONIC NEOPLASTIC LESIONS = 30 MM¿A SINGLE-CENTER EXPERIENCE."    LITERATURE SUMMARY. THE PURPOSE OF THE ANALYSIS WAS TO EVALUATE EFFICACY AND SAFETY OF FULL-THICKNESS RESECTION (FTR) IN THE TREATMENT OF COLORECTAL LESIONS = 30 MM BY COMPARING PROSPECTIVELY FOLLOWED FTR COHORT TO RETROSPECTIVE SUBMUCOSAL DISSECTION (ESD) COHORT IN THE SETTING OF SINGLE TERTIARY ENDOSCOPY CENTER. PRIMARY OUTCOMES WERE TECHNICAL SUCCESS RATE, R0 RESECTION AND CURATIVE RESECTION RATE, AND COMPLICATION RATE. A TOTAL OF 52 PATIENTS IN FTR AND 50 PATIENTS IN ESD GROUP WERE TREATED BETWEEN 2015 AND 2018. TECHNICAL SUCCESS RATE WAS SIGNIFICANTLY HIGHER IN FTR GROUP (92 VS. 74%, P = 0.01) AS WELL AS R0 RESECTION RATE (85 VS. 62%, P = 0.01) AND CURATIVE RESECTION RATE (75 VS. 56%, P = 0.01). COMPLICATIONS OCCURRED MORE FREQUENTLY IN ESD GROUP (40 VS. 13%, P = 0.002), MAINLY DUE TO HIGH INCIDENCE OF ELECTROCOAGULATION SYNDROME (24 VS. 0%). TOTAL PROCEDURE TIME WAS SUBSTANTIALLY SHORTER IN FTR GROUP (26.4 ± 11.0 MIN VS. ESTIMATED 90¿240 MIN). LOCAL RESIDUAL NEOPLASTIC LES

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14856890 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "THE USE OF ENDOSCOPIC CLIPPING IN PREVENTING DELAYED COMPLICATIONS AFTER ENDOSCOPIC RESECTION FOR SUPERFICIAL NON-AMPULLARY DUODENAL TUMORS." LITERATURE SUMMARY: THIS RETROSPECTIVE COHORT STUDY DESCRIBED THE USE OF ENDOSCOPIC CLIPPING IN PREVENTING DELAYED COMPLICATIONS AFTER ENDOSCOPIC RESECTION FOR SUPERFICIAL NON-AMPULLARY DUODENAL TUMORS. PATIENTS WERE DIVIDED INTO 2 GROUPS: THE IMMEDIATE CLIPPING GROUP (ICG) AND THE NO CLIPPING GROUP (NCG). ENDOSCOPIC MUCOSAL RESECTION (EMR) AND ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WERE PERFORMED USING EITHER TWIN-CHANNEL MULTI-BENDING GASTROSCOPES (GIF-2TQ260M; OLYMPUS) OR CONVENTIONAL GASTROSCOPES (GIF-H260 OR GIF-HQ290; OLYMPUS). AN INITIAL INCISION WAS MADE OUTSIDE THE MARKS USING EITHER A DUAL KNIFE (KD-655; OLYMPUS) OR A HOOK KNIFE (KD-620LR; OLYMPUS). AFTER ER, THE MUCOSAL DEFECT WAS CLOSED USING CLIPS (HX-610-090L; OLYMPUS ) DELIVERED BY A CLIP-FIXING DEVICE (HX 110UR; OLYMPUS). A TOTAL OF 99 LESIONS FROM 99 PATIENTS WERE INCLUDED IN THIS STUDY. FIFTY-TWO PATIENTS WERE ALLOCATED INTO ICG AND 47 PATIENTS WERE ALLOCATED INTO NCG. DELAYED BLEEDING OCCURRED IN 1 PATIENT FROM ICG AND IN 8

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14601626 ↗
• MalfunctionMar 29, 2022Problem with Sterilization; Problem with Sterilization

  THE CUSTOMER REPORTED THAT THE REUSABLE ROTATING CLIP WAS USED IN A LOWER ENDOSCOPIC PROCEDURE WITHOUT STERILIZATION AFTER ULTRASONIC CLEANING. THERE HAS BEEN NO REPORT OF PATIENT INJURY DUE TO THE EVENT. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13941949 ↗